Scleral prosthesis for treating presbyopia and other eye disorders and related devices and methods

ABSTRACT

One example scleral prosthesis includes a first free end and a second free end, each wider than a middle portion of the scleral prosthesis. Multiple first portions form the first end of the scleral prosthesis. The first portions are separated along at least half of a length of the scleral prosthesis. Multiple second portions may form the second end of the scleral prosthesis, and the second portions may be separated along less than a quarter of the length of the scleral prosthesis. An implantation device can be used to facilitate implantation of a scleral prosthesis. The implantation device includes a first end portion configured to be inserted into a scleral tunnel of an eye. The implantation device also includes a second end portion configured to receive the scleral prosthesis. A rod with a tapered and rounded end can be partially inserted into the first end portion of the implantation device.

CROSS-REFERENCE TO RELATED PATENT DOCUMENTS

This application claims priority under 35 U.S.C. §119(e) to U.S.Provisional Patent Application No. 60/819,995 filed on Jul. 11, 2006,which is hereby incorporated by reference.

This application is related to the following U.S. patent applicationsand issued patents:

-   -   (1) U.S. Pat. No. 6,007,578 entitled “Scleral Prosthesis for        Treatment of Presbyopia and Other Eye Disorders” issued on Dec.        28, 1999;    -   (2) U.S. Pat. No. 6,280,468 entitled “Scleral Prosthesis for        Treatment of Presbyopia and Other Eye Disorders” issued on Aug.        28, 2001;    -   (3) U.S. Pat. No. 6,299,640 entitled “Scleral Prosthesis for        Treatment of Presbyopia and Other Eye Disorders” issued on Oct.        9, 2001;    -   (4) U.S. Pat. No. 5,354,331 entitled “Treatment of Presbyopia        and Other Eye Disorders” issued on Oct. 11, 1994;    -   (5) U.S. Pat. No. 5,465,737 entitled “Treatment of Presbyopia        and Other Eye Disorders” issued on Nov. 14, 1995;    -   (6) U.S. Pat. No. 5,489,299 entitled “Treatment of Presbyopia        and Other Eye Disorders” issued on Feb. 6, 1996;    -   (7) U.S. Pat. No. 5,503,165 entitled “Treatment of Presbyopia        and Other Eye Disorders” issued on Apr. 2, 1996;    -   (8) U.S. Pat. No. 5,529,076 entitled “Treatment of Presbyopia        and Other Eye Disorders” issued on Jun. 25, 1996;    -   (9) U.S. Pat. No. 5,722,952 entitled “Treatment of Presbyopia        and Other Eye Disorders” issued on Mar. 3, 1998;    -   (10) U.S. Pat. No. 6,197,056 entitled “Segmented Scleral Band        for Treatment of Presbyopia and Other Eye Disorders” issued on        Mar. 6, 2001;    -   (11) U.S. Pat. No. 6,579,316 entitled “Segmented Scleral Band        for Treatment of Presbyopia and Other Eye Disorders” issued on        Jun. 17, 2003;    -   (12) U.S. Pat. No. 6,926,727 entitled “Surgical Blade for Use        with a Surgical Tool for Making Incisions for Scleral Eye        Implants” issued on Aug. 9, 2005;    -   (13) U.S. Pat. No. 6,991,650 entitled “Scleral Expansion Device        Having Duck Bill” issued on Jan. 31, 2006;    -   (14) U.S. patent application Ser. No. 10/080,877 entitled        “System and Method for Making Incisions for Scleral Eye        Implants” filed on Feb. 22, 2002;    -   (15) U.S. patent application Ser. No. 10/443,122 entitled        “System and Method for Determining a Position for a Scleral        Pocket for a Scleral Prosthesis” filed on May 20, 2003;    -   (16) U.S. patent application Ser. No. 11/137,085 entitled        “Scleral Prosthesis for Treatment of Presbyopia and Other Eye        Disorders” filed on May 24, 2005;    -   (17) U.S. patent application Ser. No. 11/199,591 entitled        “Surgical Blade for Use with a Surgical Tool for Making        Incisions for Scleral Eye Implants” filed on Aug. 8, 2005;    -   (18) U.S. patent application Ser. No. 11/252,369 entitled        “Scleral Expansion Device Having Duck Bill” filed on Oct. 17,        2005;    -   (19) U.S. patent application Ser. No. 11/323,283 entitled        “Surgical Blade for Use with a Surgical Tool for Making        Incisions for Scleral Eye Implants” filed on Dec. 30, 2005;    -   (20) U.S. patent application Ser. No. 11/323,284 entitled        “System and Method for Making Incisions for Scleral Eye        Implants” filed on Dec. 30, 2005;    -   (21) U.S. patent application Ser. No. 11/322,728 entitled        “Segmented Scleral Band for Treatment of Presbyopia and Other        Eye Disorders” filed on Dec. 30, 2005; and    -   (22) U.S. patent application Ser. No. 11/323,752 entitled        “Segmented Scleral Band for Treatment of Presbyopia and Other        Eye Disorders” filed on Dec. 30, 2005.        All of these U.S. patents and patent applications are hereby        incorporated by reference.

TECHNICAL FIELD

This disclosure is generally directed to eye implants and associateddevices, and more specifically to a scleral prosthesis for treatingpresbyopia and other eye disorders and related devices and methods.

BACKGROUND

In order for the human eye to have clear vision of an object atdifferent distances (especially near objects), the effective focallength of the eye's crystalline lens is adjusted to keep an image of theobject focused as sharply as possible on the retina. This change ineffective focal length is known as “accommodation” and is accomplishedby varying the shape of the crystalline lens in the eye. Generally, inthe unaccommodated emmetropic eye, the curvature of the lens is suchthat distant objects are sharply imaged on the retina. In theunaccommodated eye, near objects are not focused sharply on the retinabecause their images lie behind the retinal surface. In order tovisualize a near object clearly, the curvature of the crystalline lensis increased, thereby increasing its refractive power and causing theimage of the near object to fall on the retina.

The change in the shape of the crystalline lens is accomplished by theaction of certain muscles and structures within the eyeball or the“globe” of the eye. The lens is located in the forward part of the eyeimmediately behind the pupil. It has the shape of a classical biconvexoptical lens, meaning it has a generally circular cross section with twoconvex refracting surfaces. The lens is located generally on the opticalaxis of the eye, which is typically the straight line from the center ofthe cornea to the macula in the retina at the posterior portion of theglobe. In the unaccommodated eye, the curvature of the posterior surfaceof the lens (the surface adjacent to the vitreous body) is somewhatgreater than the curvature of the anterior surface.

The lens is closely surrounded by a membranous capsule that serves as anintermediate structure in the support and actuation of the lens. Thelens and its capsule are suspended on the optical axis behind the pupilby a circular assembly of radially directed elastic fibers called“zonules.” The zonules are attached at their inner ends to the lenscapsule and at their outer ends to the ciliary body and indirectly tothe ciliary muscle. The ciliary muscle is a muscular ring of tissuelocated just within the sclera, the outer supporting structure of theeye.

According to the classical theory of accommodation originating withHelmholtz, the ciliary muscle is relaxed in the unaccommodated eye andtherefore assumes its largest diameter. The relatively large diameter ofthe ciliary muscle in this condition causes a tension on the zonules,which pull radially outward on the lens capsule. This causes theequatorial diameter of the lens to increase slightly and decreases theanterior-posterior dimension of the lens at the optical axis. In otherwords, the tension on the lens capsule causes the lens to assume aflattened state where the curvature of the anterior surface, and to someextent the posterior surface, is less than it would be in the absence ofthe tension. In this state, the refractive power of the lens isrelatively low, and the eye is focused for clear vision on distantobjects.

According to the classical theory, when the eye is intended to befocused on a near object, the ciliary muscle contracts. This contractioncauses the ciliary muscle to move forward and inward, thereby relaxingthe outward pull of the zonules on the equator of the lens capsule. Thisreduced zonular tension allows the elastic capsule of the lens tocontract, causing an increase in the anterior-posterior dimension of thelens at the optical axis (meaning the lens becomes more spherical). Thisresults in an increase in the optical power of the lens. Because oftopographical differences in the thickness of the lens capsule, thecentral anterior radius of curvature may change more than the centralposterior radius of curvature. This is the accommodated condition of theeye, where images of near objects fall sharply on the retina.

Presbyopia is the universal decrease in the amplitude of accommodation,which is typically observed in individuals over forty years of age. In aperson having normal vision or “emmetropic” eyes, the ability to focuson near objects is gradually lost. As a result, the individual comes toneed glasses for tasks requiring near vision, such as reading.

According to the conventional view, the amplitude of accommodation ofthe aging eye is decreased because of the loss of elasticity of the lenscapsule and/or sclerosis of the lens with age. Consequently, even thoughthe radial tension on the zonules is relaxed by contraction of theciliary muscle, the lens does not assume a greater curvature. Accordingto this conventional view, it is not possible to restore theaccommodative power to the presbyopic eye by any treatment. The loss ofelasticity of the lens and its capsule is seen as irreversible. Onesolution to the problems presented by presbyopia is to use correctivelenses for close work or possibly bifocal lenses if corrective lensesare required for distant vision. Other solutions may include surgicallyreshaping the cornea of the eye or implanting a presbyopic intra-ocularlens in the eye

Contrary to the conventional view, it is possible to restore theaccommodative power to a presbyopic eye by implanting scleral prostheseswithin the sclera of the eye. For each individual scleral prosthesis, anincision is made in the sclera of the eye, such as near the plane of theequator of the crystalline lens. The incision is then extended under thesurface of the sclera to form a scleral “tunnel,” and a scleralprosthesis is placed within the tunnel. A typical scleral prosthesiscould be formed from a generally rectangular-shaped bar approximatelyfive millimeters long, one and a half millimeters wide, and onemillimeter tall. One or multiple scleral prostheses may be implanted ina patient's eye to partially or completely restore the accommodativepower to a presbyopic eye. The same or similar technique can also beused to treat glaucoma, ocular hypertension, elevated intraocularpressure, or other eye disorders. This technique is described more fullyin the U.S. patents and patent applications incorporated by referenceabove.

SUMMARY

This disclosure provides a scleral prosthesis for treating presbyopiaand other eye disorders and related devices and methods.

In a first embodiment, a scleral prosthesis includes a first free endand a second free end. Each of the ends is wider than a middle portionof the scleral prosthesis. Multiple first portions form the first end ofthe scleral prosthesis. The first portions are separated along at leasthalf of a length of the scleral prosthesis.

In particular embodiments, multiple second portions form the second endof the scleral prosthesis, where the second portions are separatedlengthwise along the scleral prosthesis. In other particularembodiments, the second portions are separated along less than a quarterof the length of the scleral prosthesis.

In a second embodiment, a system includes a scleral prosthesis having afirst free end and a second free end. Each end is wider than a middleportion of the scleral prosthesis. Multiple first portions form thefirst end of the scleral prosthesis, where the first portions areseparated along at least half of a length of the scleral prosthesis. Thesystem also includes a threader tube into which the first portions ofthe scleral prosthesis are at least partially inserted. The threadertube is configured to be transported through a scleral tunnel in scleraltissue of an eye and to release the scleral prosthesis for implantationof the scleral prosthesis in the scleral tunnel.

In particular embodiments, the system further includes a suture placedthrough the threader tube and looped over part of the scleralprosthesis.

In a third embodiment, an implantation device includes a first endportion configured to be inserted into a scleral tunnel in scleraltissue of an eye. The implantation device also includes a second endportion configured to receive a scleral prosthesis. The second endportion is also configured to be transported through the scleral tunnelbehind the first end portion and to release the scleral prosthesis forimplantation of the scleral prosthesis in the scleral tunnel.

In particular embodiments, the implantation device further includes arod partially inserted into the first end portion. In other particularembodiments, the rod has a tapered and rounded end.

In a fourth embodiment, a method includes inserting a scleral prosthesisinto a threader tube. The method also includes pulling the scleralprosthesis into a scleral tunnel in scleral tissue of an eye using thethreader tube. In addition, the method includes removing the scleralprosthesis from the threader tube for implantation in the scleral,tunnel.

In particular embodiments, the method further includes looping a sutureover a portion of the scleral prosthesis, where the suture is placedthrough the threader tube. The method also includes pulling the scleralprosthesis into the scleral tunnel using the suture.

In other particular embodiments, a rod extends from a first end of thethreader tube, and the rod enters the scleral tunnel before the firstend of the threader tube enters the scleral tunnel.

In a fifth embodiment, a scleral prosthesis includes a body having afirst shape at a first temperature and a second shape at a secondtemperature. The body has first and second ends that are narrower in thefirst shape and wider in the second shape. The first and second ends inthe second shape are wider than a middle portion of the body in thesecond shape.

In particular embodiments, the first shape is relatively flat, and thesecond shape is at least partially arched.

In other particular embodiments, each end includes multiple sections.The multiple sections at each end are angled towards each other in thefirst shape, and the multiple sections at each end are angled away fromeach other in the second shape.

Other technical features may be readily apparent to one skilled in theart from the following figures, descriptions, and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of this disclosure, reference is nowmade to the following description, taken in conjunction with theaccompanying drawing, in which:

FIGS. 1A and 1B illustrate a first example scleral prosthesis inaccordance with this disclosure;

FIGS. 2A and 2B illustrate a second example scleral prosthesis inaccordance with this disclosure;

FIGS. 3A through 3F illustrate a third example scleral prosthesis inaccordance with this disclosure;

FIG. 4 illustrates a fourth example scleral prosthesis in accordancewith this disclosure;

FIGS. 5A through 5G illustrate a fifth example scleral prosthesis inaccordance with this disclosure;

FIGS. 6A through 6G illustrate a sixth example scleral prosthesis inaccordance with this disclosure;

FIGS. 7A through 7G illustrate a seventh example scleral prosthesis inaccordance with this disclosure;

FIGS. 8A through 8F illustrate an example insertion of a scleralprosthesis into a patient's eye in accordance with this disclosure;

FIGS. 9A through 9C illustrate an example threader tube used to insert ascleral prosthesis into a patient's eye in accordance with thisdisclosure;

FIGS. 10A and 10B illustrate an example surgical blade used to create ascleral, tunnel for receiving a scleral prosthesis in accordance withthis disclosure;

FIGS. 11A through 11D illustrate an eighth example scleral prosthesis inaccordance with this disclosure; and

FIGS. 12A and 12B illustrate a ninth example scleral prosthesis inaccordance with this disclosure;

FIGS. 13A through 13D illustrate a tenth example scleral prosthesis inaccordance with this disclosure;

FIGS. 14A and 14B illustrate an eleventh example scleral prosthesis inaccordance with this disclosure;

FIG. 15 illustrates an example method for inserting a scleral prosthesisinto a patient's eye in accordance with this disclosure.

DETAILED DESCRIPTION

FIGS. 1A and 1B illustrate a first example scleral prosthesis 100 inaccordance with this disclosure. The embodiment of the scleralprosthesis 100 shown in FIGS. 1A and 1B is for illustration only. Otherembodiments of the scleral prosthesis 100 could be used withoutdeparting from the scope of this disclosure.

As shown in FIGS. 1A and 1B, the scleral prosthesis 100 has two opposingends 102-104, a top surface 106, and a bottom surface 108. One end 102of the prosthesis 100 includes a generally cylindrical area 110 with aflat bottom forming a base on which the prosthesis 100 sits. The otherend 104 of the prosthesis 100 is divided or split into multiple portions112 a-112 b. Each of these portions 112 a-112 b includes a generallycylindrical area 114 with a flat bottom, which collectively form anotherbase on which the prosthesis 100 sits.

In this example, the portions 112 a-112 b of the prosthesis 100 span amajority of the length of the prosthesis 100, meaning the prosthesis 100is split along at least half of its length (or some other substantialportion of its length). The portions 112 a-112 b are generally biased sothat they remain separated from one another without externalinterference. The portions 112 a-112 b may be biased such that they canbe pushed towards each other or together but then separate afterrelease. Also, the portions 112 a-112 b may not be excessively biased tothe point where they tear through an incision in the patient's eye orpull the prosthesis 100 out of a scleral tunnel. Also, the cylindricalareas 110 and 114 project out from the sides of the prosthesis 100,meaning the cylindrical areas 110 and 114 form bases that are wider thanthe middle portion of the prosthesis 100. In addition, in this example,the top surface 106 of the prosthesis 100 is generally curved, and thebottom surface 108 could be generally flat or curved.

In this example embodiment, the scleral prosthesis 100 can be implantedwithin a scleral tunnel in a patient's eye. For example, the scleralprosthesis 100 can be implanted such that the cylindrical areas 110 and114 remain outside of the scleral tunnel. Also, the flat bottoms of thecylindrical areas 110 and 114 can lie on the surface of the patient'seye outside of the scleral tunnel. To implant the scleral prosthesis 100in the scleral tunnel, the portions 112 a-112 b of the scleralprosthesis 100 could be pushed together and pulled through the scleraltunnel. This may help to reduce the width or cross-sectional area of theend 104 of the scleral prosthesis 100 as the prosthesis 100 is pulledthrough the scleral tunnel during implantation. However, any othersuitable technique could be used to implant the scleral prosthesis 100in a scleral tunnel.

The scleral tunnel in which the scleral prosthesis 100 is implanted canbe formed near the ciliary body of a patient's eye. Once implanted in ascleral tunnel, the scleral prosthesis 100 helps to, for example,increase the amplitude of accommodation of the patient's eye. Thescleral prosthesis 100 could also help to treat other eye conditions,such as glaucoma, ocular hypertension, elevated intraocular pressure, orother eye disorders. In some embodiments, multiple prostheses (such asfour) are implanted in a patient's eye, and the ends of the prosthesesare “free” (not attached to the ends of other prostheses).

By making the ends of the scleral prosthesis 100 wider than its middleportion, various benefits could be obtained, such as stabilization ofthe prosthesis 100. For example, with wider ends, it is less likely thatthe scleral prosthesis 100 would turn or rotate within a scleral tunnelafter implantation. Also, the wider ends help to lock the scleralprosthesis 100 into place and impede movement of the scleral prosthesis100. In addition, the wider ends make it less likely that the scleralprosthesis 100 can be inadvertently ejected out of the scleral tunnelafter implantation.

In particular embodiments, the prosthesis 100 in FIGURES 1A and 1B maybe formed from a single integrated piece of material, such as polymethylmethacrylate (“PMMA”), polyether-ether ketone (“PEEK”), or othersuitable material(s). Also the scleral prosthesis 100 could have anysuitable size and dimensions, and scleral prostheses 100 of differentsizes could be provided. For example, different-sized scleral prostheses100 could have different lengths, such as lengths of 3.6, 3.8, 4.0, and4.2 millimeters from the inner edges of the cylindrical areas 110 and114 of the prostheses 100.

FIGS. 2A and 2B illustrate a second example scleral prosthesis 200 inaccordance with this disclosure. The embodiment of the scleralprosthesis 200 shown in FIGS. 2A and 2B is for illustration only. Otherembodiments of the scleral prosthesis 200 could be used withoutdeparting from the scope of this disclosure.

The scleral prosthesis 200 in FIGS. 2A and 2B is similar to the scleralprosthesis 100 of FIGS. 1A and 1B. In this example embodiment, thescleral prosthesis 200 includes opposing ends 202-204. In this example,both ends 202-204 are split or divided into multiple portions 206 a-206b and 208 a-208 b, respectively. Each of these end portions 206 a-206 band 208 a-208 b includes a generally cylindrical area 210 or 212, whichcould have flat bottoms collectively define two bases for the scleralprosthesis 200.

In this example embodiment, the scleral prosthesis 200 can be implantedwithin a scleral tunnel in a patient's eye, such as by implanting thescleral prosthesis 200 so that the cylindrical areas 210 and 212 remainoutside of the scleral tunnel. Also, the flat bottom portions of thecylindrical areas 210 and 212 can lie on the surface of the patient'seye outside of the scleral tunnel. Further, the cylindrical areas 210and 212 project out from the sides of the prosthesis 200, forming basesthat are wider than the middle portion of the prosthesis 200. As notedabove, this may help to stabilize the scleral prosthesis 200, such as byreducing or preventing rotation, locking the prosthesis 200 into place,impeding movement of the prosthesis 200, and reducing the likelihoodthat the prosthesis 200 can exit the scleral tunnel. In addition, inthis example, the top surface of the prosthesis 200 is generally curved,and the bottom surface could be generally flat or curved.

To implant the scleral prosthesis 200 in the scleral tunnel, theportions 208 a-206 b or 208 a-208 b of the scleral prosthesis 200 can bepushed together and pulled through the scleral tunnel. An example ofthis is shown in FIG. 2B. Here, a tool 290 has two hooked ends 292 thatcan hook around or onto the cylindrical areas 212 of the scleralprosthesis 200. The tool 290 is then used to push the split portions 208a-208 b of the scleral prosthesis 200 together, and the prosthesis 200can be pulled into the scleral tunnel. However, any other suitabletechnique could be used to implant the scleral prosthesis 200 in ascleral tunnel.

In particular embodiments, the prosthesis 200 in FIGS. 2A and 2B may beformed from a single integrated piece of material, such as PMMA, PEEK,or other suitable material(s). The scleral prosthesis 200 could alsohave any suitable size and dimensions, and scleral prostheses 200 ofdifferent sizes could be provided.

FIGS. 3A through 3F illustrate a third example scleral prosthesis 300 inaccordance with this disclosure. The embodiment of the scleralprosthesis 300 shown in FIGS. 3A through 3F is for illustration only.Other embodiments of the scleral prosthesis 300 could be used withoutdeparting from the scope of this disclosure.

As shown in FIGS. 3A through 3C, the scleral prosthesis 300 has twoopposing ends 302-304, a top surface 306, and a bottom surface 308. Oneend 302 of the prosthesis 300 is split or divided into multiple portions310 a-310 b, and the other end 304 of the prosthesis 300 is split ordivided into multiple portions 312 a-312 b.

In this example, the portions 310 a-310 b of the prosthesis 300 spanless than a quarter of the length of the prosthesis 300 (or some otherless substantial portion of its length), and the portions 312 a-312 b ofthe prosthesis 300 span more than half of the length of the prosthesis300 (or some other more substantial portion of its length). Also, inthis example, the ends 302-304 of the prosthesis 300 have areas 314-316,respectively, that are more triangular in shape. As shown in FIG. 33,the areas 314 at the end 302 of the scleral prosthesis 300 have surfacesthat generally face the opposing end 304. Also, as shown in FIG. 33, theareas 316 at the end 304 of the scleral prosthesis 300 have surfacesthat are more hook-shaped (the areas 316 hook back towards the opposingend 302 of the scleral prosthesis 300). These areas 314 and 316 may alsoinclude generally flat bottom surfaces that form bases for theprosthesis 300.

In this example embodiment, the scleral prosthesis 300 can be implantedwithin a scleral tunnel in a patient's eye, such as by implanting thescleral prosthesis 300 so that the areas 314 and 316 remain outside ofthe scleral tunnel. Also, the flat bottom portions of the areas 314 and316 can lie on the surface of the patient's eye outside of the scleraltunnel. Further, the areas 314 and 316 project out from the sides of theprosthesis 300 to form bases wider than the middle portion of theprosthesis 300. Again, the wider ends may provide certain benefits forthe scleral prosthesis 300, such as stabilization of the prosthesis 300.In addition, in this example, the top surface 306 and the bottom surface308 of the prosthesis 300 are generally curved.

In particular embodiments, the prosthesis 300 in FIGS. 3A through 3C maybe formed from a single integrated piece of material, such as PMMA,PEEK, or other suitable material(s). Also, the scleral prosthesis 300could have any suitable size and dimensions, and scleral prostheses 300of different sizes could be provided.

Examples of differently sized and dimensioned prostheses are shown inFIGS. 3D through 3F, which illustrate four different prostheses 300a-300 d. The prostheses 300 a-300 d are similar to one another withslight changes in their structure. For example, the prosthesis 300 a hasa larger arch and flat bottom surfaces at its ends, while the prosthesis300 c has a smaller arch and flat bottom surfaces at its ends. Theprosthesis 300 b has a larger arch and slanted bottom surfaces at itsends, while the prosthesis 300 d has a smaller arch and slanted bottomsurfaces at its ends.

The prostheses 300 a-300 d in FIGS. 3D through 3F could have anysuitable sizes and dimensions. For example, the prostheses 300 a-300 dcould be 5,366 microns in length. A thickness (measured top-to-bottom)at the middle (measured end-to-end) of the prostheses 300 a-300 d couldhave various values, such as 831, 833, and 839 microns. The arch(measured from the tips of the prostheses to the top of the arch) of theprostheses 300 a-300 d could also have various values, such as 212, 311,and 386 microns.

FIG. 4 illustrates a fourth example scleral prosthesis 400 in accordancewith this disclosure. The embodiment of the scleral prosthesis 400 shownin FIG. 4 is for illustration only. Other embodiments of the scleralprosthesis 400 could be used without departing from the scope of thisdisclosure.

In this example, the scleral prosthesis 400 in FIG. 4 is similar to theprosthesis 300 shown in FIGS. 3A through 3C. Here, the scleralprosthesis 400 includes two opposing ends 402-404, where the end 404 issplit or divided into multiple portions 406 a-406 b.

The prosthesis 400 also includes an insert 408 placed between or aroundthe multiple portions 406 a-406 b of the end 404 of the prosthesis 400.The insert 408 can be permanently or removably placed between or aroundthe portions 406 a-406 b of the end 404 of the prosthesis 400. Forexample, the insert 408 could be placed between or around the portions406 a-406 b of the end 404 after the prosthesis 400 has been implantedin a scleral tunnel in a patient's eye. The insert 408 could later beremoved, such as to facilitate removal of the prosthesis 400 from thescleral tunnel.

The insert 408 may generally help to stabilize the prosthesis 400 (inaddition to the stabilization already provided by the wider ends). Forexample, the insert 408 could help to prevent the portions 406 a-406 bof the prosthesis 400 from separating excessively, which could pull theopposite end 402 through the scleral tunnel and force the prosthesis 400out of the tunnel completely. The insert 408 could also function toreduce or prevent rotation of the prosthesis 400 within the scleraltunnel. For instance, the insert 408 may help to ensure that the end 404of the prosthesis 400 maintains a desired width and therefore remainswide enough to prevent the prosthesis 400 from rolling over onceimplanted in the scleral tunnel. Moreover, the insert 408 can beinserted into or around the prosthesis 400 only after the prosthesis 400has been implanted, which enables the portions 406 a-406 b of theprosthesis 400 to be pushed together during implantation whilepreventing portions 406 a-406 b from coming together after implantation(reducing the likelihood that the prosthesis 400 can exit the scleraltunnel).

The insert 408 could be attached or coupled to the prosthesis 400 in anysuitable manner. For example, the insert 408 could have one or morestructures that engage one or more corresponding structures of theportions 406 a-406 b of the prosthesis 400, such as male structures onthe insert 408 that engage female structures on the prosthesis body. Theinsert 408 could also be attached to the prosthesis 400 using sutures orlooped around the prosthesis 400. The insert 408 could be attached orcoupled to the prosthesis 400 in any other suitable manner.

FIGS. 5A through 5G illustrate a fifth example scleral prosthesis 500 inaccordance with this disclosure. The embodiment of the scleralprosthesis 500 shown in FIGS. 5A through 5G is for illustration only.Other embodiments of the scleral prosthesis 500 could be used withoutdeparting from the scope of this disclosure.

As shown in FIG. 5A, the scleral prosthesis 500 has two opposing ends502-504. In this example, only one end 504 of the prosthesis 500 issplit or divided into multiple portions 506 a-506 b (although both couldbe). As shown in FIG. 5B, the ends of the prosthesis 500 generally havean oval cross-section. Except for the more oval cross-section and theundivided end 502, the overall shape of the prosthesis 500 is similar tothe shape of the prosthesis 300.

As shown here, portions 508-510 of the ends 502-504 of the prosthesis500 are hook-shaped, where the portions 508 of the end 502 are hookedback towards the end 504 and the portions 510 of the end 504 are hookedback towards the end 502. These portions 508-510 of the prosthesis 500could also lie outside of a scleral tunnel and rest on the surface of apatient's eye. Again, the ends 502-504 of the prosthesis 500 are widerthan the middle, helping to stabilize the prosthesis 500.

In this example, the prosthesis 500 also includes ridges 512 along theinner sides of the portions 506 a-506 b. The ridges 512 generally travellengthwise along the portions 506 a-506 b of the prosthesis 500. Theridges 512 may or may not link up to each other along the curvedintersection of the portions 506 a-506 b. The ridges 512 may have anysuitable height, width, or shape.

The prosthesis 500 could have the dimensions shown in FIGS. 5B through5G. These dimensions are for illustration only. In these figures, thedimensions are expressed as numbers in brackets (representing dimensionsin inches) over numbers without brackets (representing dimensions inmillimeters). Dimensions associated with a radius of curvature arepreceded by the letter “R” (such as in “R6.168”). In addition, thediagram shown in FIG. 5E represents the cross-section of the prosthesis500 along line A-A in FIG. 5D, and the diagram shown in FIG. 5Grepresents the cross-section of the prosthesis 500 along line B-B inFIG. 5F. As shown in FIG. 5G, the prosthesis 500 could (but need not) behollow within the undivided portion of the prosthesis 500 near the end502 and may or may not be filled with a liquid, gel, or other material.

As explained in more detail below, an insert can be placed between oraround the multiple portions 506 a-506 b of the end 504 of theprosthesis 500. The insert can be permanently or removably placedbetween or around the portions 506 a-506 b of the end 504 of theprosthesis 500. For example, the insert could be placed between oraround the portions 506 a-506 b of the end 504 after the prosthesis 500has been implanted in a scleral tunnel in a patient's eye. The insertcould later be removed, such as to facilitate removal of the prosthesis500 from the scleral tunnel.

The insert may generally help to stabilize the prosthesis 500 (inaddition to the stabilization already provided by the wider ends). Forexample, the insert could help to prevent the portions 506 a-506 b ofthe prosthesis 500 from separating excessively, which could pull theopposite end 502 through the scleral tunnel and force the prosthesis 500out of the tunnel completely. The insert could also function to reduceor prevent rotation of the prosthesis 500 within the scleral tunnel. Forinstance, the insert may help to ensure that the end 504 of theprosthesis 500 maintains a desired width and therefore remains wideenough to prevent the prosthesis 500 from rolling over once implanted inthe scleral tunnel. Moreover, the insert can be inserted into or aroundthe prosthesis 500 only after the prosthesis 500 has been implanted,which enables the portions 506 a-506 b of the prosthesis 500 to bepushed together during implantation but prevents portions 506 a-506 bfrom coming together after implantation (reducing the likelihood thatthe prosthesis 500 can exit the scleral tunnel).

FIGS. 6A through 6G illustrate a sixth example scleral prosthesis 600 inaccordance with this disclosure. The embodiment of the scleralprosthesis 600 shown in FIGS. 6A through 6G is for illustration only.Other embodiments of the scleral prosthesis 600 could be used withoutdeparting from the scope of this disclosure.

As shown in FIG. 6A, the scleral prosthesis 600 has two opposing ends602-604. In this example, again only one end 604 of the prosthesis 600is split or divided into multiple portions 606 a-606 b (although bothends could be divided). As shown in FIG. 6B, the prosthesis 600generally has a more rectangular cross-section, where the bottomsurfaces of the ends 602-604 are flatter than in the prosthesis 500.

As shown here, portions 608-610 of the ends 602-604 of the prosthesis600 are hook-shaped, and the prosthesis 600 includes ridges 612 alongthe inner sides of the portions 606 a-606 b. The ridges 612 generallytravel lengthwise along the portions 606 a-606 b of the prosthesis 600and may or may not be linked along the curved intersection of theportions 606 a-606 b. Again, the ends 602-604 of the prosthesis 600 arewider than the middle, helping to stabilize the prosthesis 600.

The prosthesis 600 could have the dimensions shown in FIGS. 6B through6G. These dimensions are for illustration only. In these figures, thedimensions are again expressed as numbers in brackets (representinginches) over numbers without brackets (representing millimeters), anddimensions associated with a radius of curvature are preceded by theletter “R.” In addition, the diagram shown in FIG. 6E represents thecross-section of the prosthesis 600 along line A-A in FIG. 6D, and thediagram shown in FIG. 6G represents the cross-section of the prosthesis600 along line B-B in FIG. 6F. Again, the prosthesis 600 may or may notbe hollow within the undivided portion of the prosthesis 600 near theend 602 and may or may not be filled with a liquid, gel, or othermaterial.

As shown below, the prosthesis 600 can include an insert permanently orremovably placed between or around the multiple portions 606 a-606 b ofthe end 604 of the prosthesis 600. The insert may generally help tostabilize the prosthesis 600 (in addition to the stabilization alreadyprovided by the wider ends).

FIGS. 7A through 7G illustrate a seventh example scleral prosthesis 700in accordance with this disclosure. The embodiment of the scleralprosthesis 700 shown in FIGS. 7A through 7G is for illustration only.Other embodiments of the scleral prosthesis 700 could be used withoutdeparting from the scope of this disclosure.

As shown in FIG. 7A, the scleral prosthesis 700 has two opposing ends702-704. Once again, in this example, only one end 704 of the prosthesis700 is split or divided into multiple portions 706 a-706 b (althoughboth could be). As opposed to prior prostheses, as shown in FIG. 7B, theprosthesis 700 does not have a symmetrical cross-section. Instead, theprosthesis 700 has one side 711 that is relatively flat along the entirelength of the prosthesis 700. Here, the ends 702-704 have sides that arealigned with each other along the side 711 of the prosthesis 700. Also,each of the ends 702-704 includes a single portion 708-710,respectively, that is hook-shaped. As a result, both ends 702-704 arestill wider than the middle portion of the prosthesis 700 and helpstabilize the prosthesis 700, but the ends 702-704 may not be as wide asprior prostheses.

As with the prostheses 500 and 600, the prosthesis 700 includes ridges712 along the inner sides of the portions 706 a-706 b. The ridges 712generally travel lengthwise along the portions 706 a-706 b of theprosthesis 700 and may or may not be linked together.

The prosthesis 700 could have the dimensions shown in FIGS. 7B through7G. These dimensions are for illustration only. The diagram shown inFIG. 7E represents the cross-section of the prosthesis 700 along lineA-A in FIG. 7D, and the diagram shown in FIG. 7G represents thecross-section of the prosthesis 700 along line B-B in FIG. 7F. Also, theprosthesis 700 may or may not be hollow within the undivided portion ofthe prosthesis 700 near the end 702 and may or may not be filled with aliquid, gel, or other material. As explained below, the prosthesis 700may include an insert permanently or removably placed between or aroundthe multiple portions 706 a-706 b of the end 704 of the prosthesis 700.The insert may generally help to stabilize the prosthesis 700 (inaddition to the stabilization already provided by the wider ends).

Although FIGS. 1A through 7G illustrate various examples of scleralprostheses, various changes may be made to FIGS. 1A through 7G. Forexample, the sizes, shapes, and dimensions of the features of thescleral prostheses are for illustration only and can be altered in anysuitable manner. Also, various features shown and described with respectto one of the scleral prostheses could be used with other scleralprostheses. As a particular example, the insert 408 of the prosthesis400 could be used with any other suitable scleral prosthesis. As anotherparticular example, a difference between the prostheses shown in FIGS.3A-3F and the prostheses shown in FIGS. 5A-7G is that (when looking froman end viewpoint) the top edges of the ends have been shaved in FIGS.5A-7G so that they slope downwards from top to bottom at about a 45°angle. This same feature could be used with any other prosthesis.

FIGS. 8A through 8F illustrate an example insertion of a scleralprosthesis into a patient's eye in accordance with this disclosure. Theexample insertion of the scleral prosthesis shown in FIGS. 8A through 8Fis for illustration only. Other techniques could be used to insert ascleral prosthesis into a patient's eye without departing from the scopeof this disclosure.

As shown in FIG. 8A, a prosthesis 800 is being implanted into a scleraltunnel 802 in a patient's eye. The prosthesis 800 could represent anysuitable prosthesis, such as one of the prostheses discussed above orany other suitable prosthesis. In this example, the prosthesis 800 isinserted into a threader tube 804, which is used to compress or pushtogether the split or divided portions of the prosthesis 800 forinsertion into the scleral tunnel 802. The prosthesis 800 is pulled intothe scleral tunnel 802 by the threader tube 804 and, optionally, asuture 806 that has been threaded through the scleral tunnel 802. Theend of the suture 806 in this example includes two loops that are placedthrough the threader tube 804 and connected to one end of the prosthesis800. In this example, the loops of the suture 806 loop around thecylindrical or triangular areas at one end of the prosthesis 800.

As shown in FIGS. 8A and 8B, one end of the prosthesis 800 is connectedto the suture 806 and can be inserted into the threader tube 804. Asshown in FIGS. 8C and 8D, the threader tube 804 and the suture 806 canthen be pulled so that the prosthesis 800 is pulled into the scleraltunnel 802. In some embodiments, the prosthesis 800 is both pulled intothe scleral tunnel 802 (such as by using the threader tube 804 and/orthe suture 806) and pushed into the scleral tunnel 802 (such as by usingan instrument held by a surgeon). As shown in FIG. 8E, once theprosthesis 800 is implanted within the scleral tunnel 802, the threadertube 804 can be pulled off the prosthesis 800, and the suture 806 can beremoved from the prosthesis 800. This leaves the prosthesis 800 in thescleral tunnel 802 as shown in FIG. 8F.

Although FIGS. 8A through 8F illustrate one example of an insertion of ascleral prosthesis into a patient's eye, various changes may be made toFIGS. 8A through 8F. For example, the threader tube 804 could have anysuitable size or shape. Also, the suture 806 could be attached orcoupled to the prosthesis 800 in any suitable manner. In addition, thesuture 806 need not be used with the threader tube 804 to implant theprosthesis 800. In particular embodiments, the prosthesis 800 could bepulled into the scleral tunnel 802 using only the threader tube 804.

FIGS. 9A through 9C illustrate an example threader tube 900 used toinsert a scleral prosthesis into a patient's eye in accordance with thisdisclosure. The embodiment of the threader tube 900 shown in FIGS. 9Athrough 9C is for illustration only. Other embodiments of the threadertube 900 could be used without departing from the scope of thisdisclosure.

In this example, the threader tube 900 includes a wider upper portion902, a tapered portion 904, and a narrower lower portion 906. The lowerportion 906 in this example includes an angled end 908. The threadertube 900 could be formed from any suitable material(s), such asheat-shrink tubing formed from TEFLON PTFE (polytetrafluoroethylene).Also, the threader tube 900 could have any suitable shape that allowsthe threader tube 900 to be pulled through a scleral tunnel. Forexample, the threader tube 900 could have an overall length of 3.0 cm(+0.5 cm). The upper portion 902 could have a length of 1.0 cm (+0.2cm), an internal diameter of 1.0 mm, and a minimum wall thickness of0.08 mm. The lower portion 906 could have an internal diameter of 0.5 mmand a recovered minimum wall thickness of 0.12 mm. In addition, the end908 of the lower portion 906 could have an angle of 30°.

Optionally, a suture 910 can be placed through the threader tube 900,and a rod 912 can be inserted into the lower portion 906 of the threadertube 900. The illustration in FIG. 9C represents the cross-section ofthe threader tube 900 along the lower portion 906 of the threader tube900. The suture 910 travels through the threader tube 900, loops arounda scleral prosthesis 914, and returns through the threader tube 900. Thesuture 910 in this example loops around the central body of theprosthesis 914 (as opposed to looping over portions of the closer end ofthe prosthesis as shown in FIGS. 8A through 8F). The suture 910represents any suitable suture made of any suitable material(s), such as6-0 NYLON or PROLENE sutures having a 0.1 mm diameter.

The rod 912 in this example includes a tapered and rounded end that canbe inserted through a scleral tunnel ahead of the lower portion 906 ofthe threader tube 900. The rod 912 can be used to facilitate insertionof the threader tube 900 into a scleral tunnel of a patient's eye. Forexample, the rod 912 may help the scleral tunnel to open and obtain alarger size before the lower portion 906 of the threader tube 900 isinserted into the scleral tunnel. The rod 912 could be formed from anysuitable material(s) and can have any suitable size or shape, such as acigar-shaped rod having a maximum diameter of 0.3 mm. Also, both ends ofthe rod 912 could, but need not, have the shape shown in FIG. 9B.

Although FIGS. 9A through 9C illustrate one example of a threader tube900 used to insert a scleral prosthesis into a patient's eye, variouschanges may be made to FIGS. 9A through 9C. For example, the threadertube 900 and rod 912 could have any suitable size or shape. Also, thesuture 910 need not loop around the central body of the prosthesis 914and could loop around or be attached to or associated with theprosthesis 914 in any suitable manner, such as by being looped aroundthe closer end of the prosthesis 914. Further, the suture 910 and/or therod 912 need not be used along with the threader tube 900 to insert ascleral prosthesis into a scleral tunnel.

FIGS. 10A and 10B illustrate an example surgical blade 1000 used tocreate a scleral tunnel for receiving a scleral prosthesis in accordancewith this disclosure. The embodiment of the surgical blade 1000 shown inFIGS. 10A and 10B is for illustration only. Other embodiments of thesurgical blade 1000 could be used without departing from the scope ofthis disclosure.

In this example, the surgical blade 1000 is used to automatically feed asuture through a scleral tunnel. The suture could then be used to pull aprosthesis into the scleral tunnel, such as is shown in FIGS. 8A through8F and 9A through 9C. However, as noted above, the use of a suture topull a prosthesis into a scleral tunnel is not required, and thesurgical blade 1000 could be modified to simply form a scleral tunnelwithout pulling a suture through the tunnel.

As shown in FIGS. 10A and 10B, the surgical blade 1000 includes acentral portion 1002, a curved cutting blade 1004, and a connectingsegment 1006. The central portion 1002 is connected to a surgical tooland can be rotated in multiple directions to move the cutting blade 1004into and out of the scleral tissue of a patient's eye. The connectingsegment 1006 couples the central portion 1002 to the cutting blade 1004,helping to translate rotation of the central portion 1002 into movementof the cutting blade 1004.

In this example, the cutting blade 1004 includes a notch 1008. After thecutting blade 1004 is rotated into the scleral tissue of a patient's eye(and before it is rotated out of the scleral tissue), a suture 1010 canbe placed in the notch 1008. In some embodiments, the suture 1010 couldhave multiple loops at its end, and the loops may be placed in the notch1008. In other embodiments, the suture 1010 itself is placed within thenotch 1008. The suture 1010 could be loaded into the notch 1008 in anysuitable manner, such as automatically or manually. The cutting blade1004 is then rotated out of the patient's scleral tissue, pulling thesuture 1010 with it. This allows the suture 1010 to be pulled throughthe scleral tunnel in a patient's eye at the time that the scleraltunnel is formed. The suture 1010 also helps to mark the location of thescleral tunnel, allowing a surgeon or other personnel to quickly locatethe scleral tunnel in the patient's eye after the surgical blade 1000 isremoved.

Although FIGS. 10A and 10B illustrate one example of a surgical blade1000 used to create a scleral tunnel for receiving a scleral prosthesis,various changes may be made to FIGS. 10A and 10B. For example, thesurgical blade 1000 need not include a notch 1008, and the suture 1010could be inserted through a scleral tunnel after the tunnel is formed.Also, as noted above, the suture 1010 could be omitted from the surgicalprocedure.

FIGS. 11A through 11D illustrate an eighth example scleral prosthesis1100 in accordance with this disclosure. The embodiment of the scleralprosthesis 1100 shown in FIGS. 11A through 11D is for illustration only.Other embodiments of the scleral prosthesis 1100 could be used withoutdeparting from the scope of this disclosure.

In this example, the scleral prosthesis 1100 changes shape after beingimplanted into a scleral tunnel. For example, the prosthesis 1100 couldbe formed from a shape-memory metal or other material that changes shapewhen exposed to certain temperatures or temperature ranges, such as anickel titanium alloy or Nitinol. In this example, the prosthesis 1100before implantation may have the shape shown in FIG. 11A. Here, theprosthesis 1100 includes a generally flat central portion 1102 and twogenerally flat end portions 1104-1106. Each of the end portions1104-1106 includes two separated sections 1108, which in this exampleare angled towards one another.

Once inserted into a scleral tunnel, the temperature of the patient'sscleral tissue may cause the prosthesis 1100 to assume the shape shownin FIG. 11B. The central portion 1102 of the prosthesis 1100 is nowarched or curved, and the sections 1108 of each end portion 1104-1106angle away from one other. Also, the end portions 1104-1106 may begenerally curved, while the tips of the end portions 1104-1106 areflatter to form splayed feet that provide support for the prosthesis1100.

The prosthesis 1100 could be implanted into a patient's eye in anysuitable manner. For example, the scleral prosthesis 1100 could beinserted into a scleral tunnel after a surgical blade has been used toform the scleral tunnel.

In other embodiments, as shown in FIG. 11C, the prosthesis 1100 could beplaced within a sheath 1152 having an integrated blade 1154. Theintegrated blade 1154 can be used to form a scleral tunnel in apatient's eye while the prosthesis 1100 is being inserted into thescleral tissue. For example, as shown in FIG. 11D, a vacuum pot 1170 canbe inserted onto a patient's eye, and vacuum forces could be used topull up on the patient's scleral 1172 and conjunctiva 1174. At thispoint, an incision could be formed in the patient's eye, such as anincision at location 1176. This could include inserting the prosthesis1100 into the patient's eye at the location 1176, using the blade 1154to cut into and form an incision through the patient's eye at thatlocation. By pulling up on the patient's sclera 1172 before the incisionis formed, a straight incision rather than a curved incision could beused to form a scleral tunnel. Although the incision is shown asoccurring outside of the vacuum pot 1170, the vacuum pot 1170 couldinclude a mechanism for forming an incision inside the vacuum pot 1170.Once implanted, the sheath 1152 could be opened and pulled through thescleral tunnel while the prosthesis 1100 is maintained in place (such asby a surgeon using a gripping tool to hold the prosthesis 1100 inplace). However, the prosthesis 1100 could be inserted in any othersuitable manner, with or without using a sheathe, integrated blade, orvacuum pot.

In particular embodiments, the prosthesis 1100 may be malleable andcaused to assume the shape shown in FIG. 11A at lower temperatures (in a“martensite” phase), such as temperatures below 60° F. At temperaturesabove 60° F. (in an “austenite” phase), the prosthesis 1100 may assumethe arched shape shown in FIG. 11B. The flatter shape of the prosthesis1100 shown in FIG. 11A may help to reduce the profile of the prosthesis1100 during implantation, which may reduce the size of an incisionneeded in the scleral tissue of a patient's eye. As a particularexample, the prosthesis 1100 in FIG. 11A could have an arched height of250 microns, and the prosthesis 1100 in FIG. 11B could have an archedheight of 900 microns. Also, because the prosthesis 1100 in FIG. 11A isgenerally flat, a straight incision could be used to form a scleraltunnel instead of a curved incision, reducing the complexity of formingthe incision.

Although FIGS. 11A through 11D illustrate an eighth example scleralprosthesis 1100, various changes may be made to FIGS. 11A through 11D.For example, the prosthesis 1100 could have any suitable size or shapebefore and after implantation. As a particular example, while shown asincluding separated sections 1108 at its ends 1104-1106 in FIG. 11A,each end 1104-1106 of the prosthesis 1100 could be fully integrated, andeach end 1104-1106 may branch into multiple sections 1108 only afterimplantation.

FIGS. 12A through 143 illustrate additional example prostheses havinginserts placed between portions or “legs” of one end of each of theseprostheses. FIGS. 12A and 12B illustrate a ninth example scleralprosthesis 1200 in accordance with this disclosure. The embodiment ofthe scleral prosthesis 1200 shown in FIGS. 12A and 12B is forillustration only. Other embodiments of the scleral prosthesis 1200could be used without departing from the scope of this disclosure.

In this example, the scleral prosthesis 1200 is configured to receive aninsert 1202. The prosthesis 1200 includes a textured bottom surface1204, and the insert 1202 includes a textured bottom surface 1206(although this feature could be omitted). Also, the interior sides ofthe legs of the prosthesis 1200 have “male” ridges 1208, and the insert1202 has “female” slots 1210 that guide the insert 1202 smoothly betweenthe legs of the prosthesis 1200 (after the prosthesis 1200 itself hasbeen inserted in a scleral tunnel).

In addition, the insert 1202 includes a slightly wider circular “male”area 1212 at the interior end of the insert 1202, which can be insertedinto a corresponding circular “female” expansion 1214 on the prosthesis1200 itself. As the insert 1202 approaches the end of its travel intothe prosthesis 1200, the area 1212 can be snapped into the expansion1214, which helps to ensure that the insert 1202 does not fall out ofthe prosthesis 1200 after implantation.

The insert 1212 can be permanently or removably placed between the legsof the prosthesis 1200. For example, the insert 1212 could be placedbetween the legs of the prosthesis 1200 after the prosthesis 1200 hasbeen implanted in a scleral tunnel in a patient's eye. The insert 1212could later be removed, such as to facilitate removal of the prosthesis1200 from the scleral tunnel.

The insert 1212 may generally help to stabilize the prosthesis 1200 (inaddition to the stabilization already provided by its wider ends). Forexample, the insert 1212 could help to prevent the legs of theprosthesis 1200 from separating excessively, which could pull theopposite end through the scleral tunnel and force the prosthesis 1200out of the tunnel completely. The insert 1212 could also function toreduce or prevent rotation of the prosthesis 1200 within the scleraltunnel. For instance, the insert 1212 may help to ensure that the legsof the prosthesis 1200 form an end having a desired width, so the endremains wide enough to prevent the prosthesis 1200 from rolling overonce implanted in the scleral tunnel. Moreover, the insert 1212 can beinserted into or around the prosthesis 1200 only after the prosthesis1200 has been implanted, which enables the legs of the prosthesis 1200to be pushed together during implantation but prevents the legs fromcoming together after implantation.

FIGS. 13A through 13D illustrate a tenth example scleral prosthesis1300, 1350 in accordance with this disclosure. The embodiments of thescleral prostheses 1300, 1350 shown in FIGS. 13A through 13D are forillustration only. Other embodiments of the scleral prostheses 1300,1350 could be used without departing from the scope of this disclosure.

As shown in FIGS. 13A and 133, an insert 1302 can be placed between thelegs of the prosthesis 1300. Similarly, as shown in FIGS. 13C and 13D,an insert 1352 can be placed between the legs of the prosthesis 1350.The inserts 1302 and 1352 can function in the same or similar manner asthe insert 1202 described above. Moreover, the same mechanisms (maleridges, female slots, male areas, and female expansions) could be usedwith the prostheses 1300, 1350 and inserts 1302, 1352.

FIGS. 14A and 14B illustrate an eleventh example scleral prosthesis inaccordance with this disclosure. The embodiment of the scleralprosthesis 1400 shown in FIGS. 14A and 14B is for illustration only.Other embodiments of the scleral prosthesis 1400 could be used withoutdeparting from the scope of this disclosure.

As shown in FIGS. 14A and 14B, an insert 1402 can be placed between thelegs of the prosthesis 1400. The insert 1402 can function in the same orsimilar manner as the insert 1202 described above. Moreover, the samemechanisms (male ridges, female slots, male areas, and femaleexpansions) could be used with the prosthesis 1400 and insert 1402.

In particular embodiments, the prostheses 1200-1400 Shown in FIGS. 12Athrough 14B represents the same or similar prostheses described above inFIGS. 5A through 7G. However, the inserts could be used with any othersuitable prosthesis.

Although FIGS. 12A through 143 illustrate various examples of scleralprostheses having inserts, various changes may be made to FIGS. 12Athrough 143. For example, the sizes, shapes, and dimensions of thefeatures of the scleral prostheses are for illustration only and can bealtered in any suitable manner. Also, various features shown anddescribed with respect to one of the scleral prostheses could be usedwith other scleral prostheses (including the prostheses shown in FIGS. 1through 7G).

FIG. 15 illustrates an example method 1500 for inserting a scleralprosthesis into a patient's eye in accordance with this disclosure. Themethod 1500 shown in FIG. 15 is for illustration only. Other techniquescould be used to insert a scleral prosthesis into a patient's eyewithout departing from the scope of this disclosure.

A scleral tunnel is formed in a patient's eye and a suture is placedthrough the scleral tunnel at step 1502. This could include, forexample, using a tool with a curved cutting blade to form the scleraltunnel. This may also include pulling a suture through the scleraltunnel using the curved cutting blade. This may further include pullinga suture through the scleral tunnel after the curved cutting blade hascompleted the formation of the tunnel.

The suture is looped around a scleral prosthesis at step 1504. Thiscould include, for example, placing loops at the end of a suture aroundone end of the scleral prosthesis (such as is done in FIGS. 8A through8F). This could also include looping a suture around the central bodyportion of the scleral prosthesis (such as is done in FIGS. 9A through9C). This step may also involve placing the suture through a threadertube.

The scleral prosthesis is inserted into the threader tube at step 1506.This could include, for example, inserting one end of the scleralprosthesis into the threader tube. Any suitable portion of the scleralprosthesis can be inserted into the threader tube, such as a portionthat prevents premature ejection of the scleral prosthesis within thescleral tunnel.

The threader tube is inserted into the scleral tunnel at step 1508. Thiscould include, for example, pushing the lower portion 906 of thethreader tube into the scleral tunnel. This could also include pullingthe threader tube into the scleral tunnel using the suture. This couldfurther include using the rod 915 to open the scleral tunnel before thebody of the threader tube is pulled into the scleral tunnel. The scleralprosthesis is pulled into the scleral tunnel at step 1510. This couldinclude, for example, pulling the scleral prosthesis into its properposition within the scleral tunnel using the threader tube and thesuture.

The scleral prosthesis is removed from the threader tube at step 1512,and the threader tube and the suture are removed at step 1514. Thiscould include, for example, pulling the threader tube off the scleralprosthesis. This could also include pulling on one end of the suture toremove the suture from the scleral tunnel.

If necessary or desired, an insert can be placed between or aroundportions of the implanted scleral prosthesis at step 1516. This couldinclude, for example, placing the insert between or around separated ordivided portions of the scleral prosthesis to prevent rotation, flexing,ejection, or other movement by the scleral prosthesis.

Although FIG. 15 illustrates one example of a method 1500 for insertinga scleral prosthesis into a patient's eye, various changes may be madeto FIG. 15. For example, any other suitable technique could be used toplace a suture through the scleral tunnel. Also, any other suitabletechnique could be used to pull or push the scleral prosthesis into thescleral tunnel, including techniques omitting the use of a suture orrod.

It may be advantageous to set forth definitions of certain words andphrases used throughout this patent document. The terms “include” and“comprise,” as well as derivatives thereof, mean inclusion withoutlimitation. The term “or” is inclusive, meaning and/or. The phrases“associated with” and “associated therewith,” as well as derivativesthereof, may mean to include, be included within, interconnect with,contain, be contained within, connect to or with, couple to or with, becommunicable with, cooperate with, interleave, juxtapose, be proximateto, be bound to or with, have, have a property of, or the like.

While this disclosure has described certain embodiments and generallyassociated methods, alterations and permutations of these embodimentsand methods will be apparent to those skilled in the art. Accordingly,the above description of example embodiments does not define orconstrain this disclosure. Other changes, substitutions, and alterationsare also possible without departing from the spirit and scope of thisdisclosure, as defined by the following claims.

1.-32. (canceled)
 33. A scleral prosthesis comprising: a body having afirst shape at a first temperature and a second shape at a secondtemperature, the body having first and second ends that are narrower inthe first shape and wider in the second shape, the first and second endsin the second shape being wider than a middle portion of the body in thesecond shape.
 34. The scleral prosthesis of claim 33, wherein: the firstshape is relatively flat; and the second shape is at least partiallyarched.
 35. The scleral prosthesis of claim 33, wherein each endcomprises multiple sections, the multiple sections at each end angledtowards each other in the first shape, the multiple sections at each endangled away from each other in the second shape.
 36. The scleralprosthesis of claim 33, wherein the body is formed from a shape-memorymaterial.
 37. The scleral prosthesis of claim 33, wherein the secondtemperature comprises a temperature associated with scleral tissue of apatient's eye.
 38. The scleral prosthesis of claim 36, wherein theshape-memory material comprises a shape-memory metal.
 39. The scleralprosthesis of claim 38, wherein the shape-memory metal comprises nickeltitanium alloy.
 40. The scleral prosthesis of claim 33, wherein thefirst and second ends in the second shape form splayed feet, eachsplayed foot comprising a curved portion and a flatter tip.
 41. Thescleral prosthesis of claim 33, wherein: the first shape is arched to asmaller degree; and the second shape is arched to a larger degree.
 42. Asystem comprising: a scleral prosthesis comprising a body having a firstshape at a first temperature and a second shape at a second temperature,the body having first and second ends that are narrower in the firstshape and wider in the second shape, the first and second ends in thesecond shape being wider than a middle portion of the body in the secondshape; and a sheath having a blade configured to cut scleral tissue of apatient's eye to form an incision, the scleral prosthesis located withinthe sheath.
 43. The system of claim 42, wherein the blade comprises astraight blade.
 44. The system of claim 42, wherein: the first shape isrelatively flat; and the second shape is at least partially arched. 45.The system of claim 42, wherein: the first shape is arched to a smallerdegree; and the second shape is arched to a larger degree.
 46. Thesystem of claim 42, wherein each end of the body comprises multiplesections, the multiple sections at each end angled towards each other inthe first shape, the multiple sections at each end angled away from eachother in the second shape.
 47. The system of claim 42, wherein the bodyis formed from a shape-memory material.
 48. The system of claim 47,wherein the shape-memory material comprises a shape-memory metal. 49.The system of claim 48, wherein the shape-memory metal comprises nickeltitanium alloy.
 50. The system of claim 42, wherein the secondtemperature comprises a temperature associated with the scleral tissueof the patient's eye.
 51. The system of claim 42, wherein the first andsecond ends in the second shape form splayed feet, each splayed footcomprising a curved portion and a flatter tip.
 52. A method comprising:implanting a scleral prosthesis into scleral tissue of a patient's eye;wherein the scleral prosthesis comprises a body having a first shape ata first temperature and a second shape at a second temperature, the bodyhaving first and second ends that are narrower in the first shape andwider in the second shape, the first and second ends in the second shapebeing wider than a middle portion of the body in the second shape; andwherein the scleral prosthesis is implanted into the scleral tissue ofthe patient's eye while having the first shape.